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Developing a New LIFU Neuromodulation Method to Suppress Tremor

NCT07103265 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-08-05

No results posted yet for this study

Summary

The investigators aim to apply low intensity focused ultrasound neuromodulation to patients with essential tremor to evaluate the efficacy of this intervention in reducing the amplitude of hand tremor compared to sham stimulation.

Conditions

Interventions

DEVICE

Transcranial focused ultrasound stimulation

Parameters Range of values Fundamental frequency 250 kHz Transducer diameter 15 cm Focal distance 13.5 cm (steerable +/- 5-10 mm from the center) Pulse repetition frequency 100 Hz Duty cycle 10% Duration 2 min for each of the 7 foci Peak spatial intensity (Isppa) 10.0 W/cm2 Peak temporal average intensity (Ispta) 1.2 W/cm2 Mechanical index (MI) 0.48 \* Thermal index (TI) 0.8oC \*\*

DEVICE

Sham stimulation

Same set-up as for real stimulation but with without delivering any ultrasound stimulation

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-15
Primary Completion
2027-07-15
Completion
2027-07-15

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103265 on ClinicalTrials.gov